REYVOW Drug Patent Profile

When do Reyvow patents expire, and what generic alternatives are available?

Reyvow is a drug marketed by Eli Lilly And Co and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-eight patent family members in forty-seven countries.

The generic ingredient in REYVOW is lasmiditan succinate. One supplier is listed for this compound. Additional details are available on the lasmiditan succinate profile page.

DrugPatentWatch^® Generic Entry Outlook for Reyvow

Reyvow was eligible for patent challenges on January 31, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 5, 2037. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for REYVOW

International Patents:	168
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Patent Applications:	160
Drug Prices:	Drug price information for REYVOW
What excipients (inactive ingredients) are in REYVOW?	REYVOW excipients list
DailyMed Link:	REYVOW at DailyMed

See drug prices for REYVOW

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for REYVOW

Constraining patent/regulatory exclusivity:

11,053,214

NDA:

211280

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Paragraph IV (Patent) Challenges for REYVOW

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REYVOW	Tablets	lasmiditan succinate	50 mg and 100 mg	211280	1	2024-01-31

US Patents and Regulatory Information for REYVOW

REYVOW is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,053,214.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No	7,423,050		Y	Y
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-002	Jan 31, 2020		RX	Yes	Yes	12,257,246
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No	12,071,423		Y

Expired US Patents for REYVOW

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020	8,748,459
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-002	Jan 31, 2020	8,748,459
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-003	Dec 18, 2020	8,748,459

International Patents for REYVOW

When does loss-of-exclusivity occur for REYVOW?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering REYVOW around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3201026	PROCEDES ET INTERMEDIAIRE POUR LA PREPARATION A GRANDE ECHELLE DE ,4,6,-TRIFLUORO-N-[6-(1-METHYLE-PIPERIDINE-4-CARBONYLE)-PYRIDINE-2-YL]-H EMISUCCINATE DE BENZAMIDE ET LA PREPARATION DE 2,4,6-TRIFLUORO-N-[6-(1-METHYLR-PIPERIDINE-4-CARBONYLE)-PYRIDINE-2-YL]-ACETATE DE BENZAMIDE (PROCESSES AND INTERMEDIATE FOR THE LARGE-SCALE PREPARATION OF 2,4,6-TRIFLUORO-N-[6-(1-METHYL-PIPERIDINE-4-CARBONYL)-PYRIDIN-2-YL]-BENZAMIDE HEMISUCCINATE, AND PREPARATION OF 2,4,6-TRIFLUORO-N-[6-(1-METHYL-PIPERIDINE-4-CARBONYL)-PYRIDIN-2-YL]-BENZAMIDE ACETATE)
Ukraine	124433	ПІРИДИНОЇЛПІПЕРИДИН, ЙОГО ЗАСТОСУВАННЯ ДЛЯ ЛІКУВАННЯ МІГРЕНІ ТА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ НА ЙОГО ОСНОВІ (COMPOSITIONS AND METHODS RELATED TO PYRIDINOYLPIPERIDINE 5-HT1F AGONISTS)
Lithuania	3551617

Supplementary Protection Certificates for REYVOW

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2413933	PA2023502,C2413933	Lithuania		PRODUCT NAME: LASMIDITANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/21/1587 20220817
2413933	CA 2023 00001	Denmark		PRODUCT NAME: LASMIDITAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1587 20220819
2413933	LUC00295	Luxembourg		PRODUCT NAME: LASMIDITAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (RAYVOW); AUTHORISATION NUMBER AND DATE: EU/1/21/1587 20220819

Market Dynamics and Financial Trajectory for REYVOW (Lasmiditan)

Introduction to REYVOW

REYVOW (lasmiditan) is a groundbreaking oral medication approved by the U.S. Food and Drug Administration (FDA) in October 2019 for the acute treatment of migraine with or without aura in adults. Developed by Eli Lilly and Company, REYVOW marks a significant advancement in migraine treatment, being the first and only FDA-approved medicine in the new class of serotonin (5-HT)1F receptor agonists[3].

Unique Mechanism of Action

REYVOW distinguishes itself from existing treatments, particularly triptans, through its unique mechanism of action. Unlike triptans, REYVOW does not cause vasoconstriction, thereby eliminating cardiovascular side effects, a major unmet need in the current market. This makes it an attractive option for patients who are unresponsive to triptans or have cardiovascular issues[1][3].

Market Positioning

Eli Lilly's strategic move to acquire the licensing and commercialization rights of lasmiditan from CoLucid Pharmaceuticals in 2017 for $960 million has positioned the company as a leading player in the highly competitive migraine market. With REYVOW, Lilly now offers both acute and preventative treatments, enhancing its market presence and future sales growth[1].

Competitive Landscape

REYVOW enters a market where it faces competition from other recent approvals, notably Allergan’s Ubrelvy (ubrogepant), the first oral calcitonin gene-related peptide (CGRP) agonist. However, REYVOW’s unique mechanism and lack of cardiovascular side effects give it a competitive edge. Additionally, Lilly’s existing preventative migraine drug, Emgality (galcanezumab), complements REYVOW, offering a comprehensive treatment portfolio[1][4].

Clinical Efficacy and Patient Response

Clinical trials, including the Phase 3 development program and the open-label GLADIATOR study, have demonstrated REYVOW’s efficacy. In these studies, 28% to 39% of patients achieved complete relief from migraine pain after two hours, compared to 15% and 21% for placebo. A higher number of patients, 41% to 49%, experienced relief from their most bothersome symptom[3][4].

Financial Projections

GlobalData forecasts REYVOW to generate global sales of $584 million by 2025, capturing a share from triptan prescriptions for unresponsive patients and those with cardiovascular problems. This projection underscores the significant financial potential of REYVOW in the migraine market[1].

Pricing and Availability

REYVOW was launched in early 2020, priced at $640 for a package of eight tablets. This pricing strategy, combined with its unique benefits, is expected to attract patients seeking new acute migraine treatments. The drug’s availability in retail pharmacies further enhances its market accessibility[4].

Market Need and Impact

Migraines affect over 30 million adults in the U.S. and are the second-leading cause of disability worldwide. The condition results in an estimated $56 billion in lost productivity annually. REYVOW addresses this significant unmet need by providing an innovative treatment option that can help decrease the disease burden. Patients and doctors are eager for new options, with 79% of migraine sufferers willing to try another acute medicine[4].

Regulatory Approval and Scheduling

Following FDA approval in October 2019, REYVOW received scheduling from the Drug Enforcement Administration (DEA) in January 2020. This regulatory clearance was crucial for its market launch and availability to patients. The DEA scheduling process also addressed concerns about abuse potential, which, while present, is considered manageable based on the human abuse potential studies conducted by Lilly[3][4].

Abuse Potential and Safety

REYVOW has shown abuse potential in clinical studies, but at a level lower than that of alprazolam. The drug is associated with adverse events such as euphoria and hallucinations, though these occur at a low frequency (about 1% of patients). Lilly emphasizes the need to evaluate patients for risk of drug abuse and to monitor for signs of lasmiditan misuse or abuse[3].

Long-Term Safety Data

One of the challenges for REYVOW’s uptake is the need for more long-term safety data. Lilly is committed to providing this data to reassure doctors and patients about the drug’s safety profile over extended use[1].

Financial Performance of Eli Lilly

The launch of REYVOW is part of Eli Lilly’s broader strategy to drive growth through innovative medicines. In 2019, Lilly reported strong financial performance, with revenue growth driven by key products launched since 2014. The company’s operating income increased by 41% compared to 2018, and it is positioned for top-tier growth through 2025, with few patent expirations anticipated in the near future[5].

Conclusion

REYVOW represents a significant advancement in the treatment of acute migraine, offering a unique mechanism of action and addressing unmet needs in the market. With strong clinical efficacy, favorable market positioning, and robust financial projections, REYVOW is poised to contribute substantially to Eli Lilly’s growth and dominance in the migraine treatment market.

Key Takeaways

• Unique Mechanism: REYVOW is the first FDA-approved serotonin (5-HT)1F receptor agonist for acute migraine treatment.
• Market Positioning: Eli Lilly’s acquisition of lasmiditan rights positions the company as a leader in the migraine market.
• Competitive Edge: REYVOW’s lack of cardiovascular side effects and unique mechanism give it an edge over competitors.
• Financial Projections: Forecasted to generate $584 million in global sales by 2025.
• Clinical Efficacy: Demonstrated significant relief from migraine pain and symptoms in clinical trials.
• Regulatory Approval: Received FDA approval and DEA scheduling, ensuring market availability.
• Safety and Abuse Potential: Associated with low-frequency adverse events; long-term safety data is being gathered.

FAQs

What is REYVOW and how does it work?

REYVOW (lasmiditan) is an oral medication approved for the acute treatment of migraine with or without aura in adults. It works by binding to serotonin (5-HT)1F receptors, a unique mechanism that distinguishes it from other treatments like triptans.

How effective is REYVOW in treating migraines?

Clinical trials have shown that REYVOW provides significant relief from migraine pain and symptoms. Between 28% to 39% of patients achieved complete relief from migraine pain after two hours, compared to 15% and 21% for placebo.

What are the potential side effects of REYVOW?

REYVOW is associated with adverse events such as euphoria and hallucinations, though these occur at a low frequency (about 1% of patients). It also has abuse potential, but at a level lower than that of alprazolam.

How does REYVOW compare to other migraine treatments?

REYVOW stands out due to its unique mechanism of action and lack of cardiovascular side effects, making it a preferred option for patients who are unresponsive to triptans or have cardiovascular issues.

What is the pricing and availability of REYVOW?

REYVOW is priced at $640 for a package of eight tablets and is available in retail pharmacies following its launch in early 2020.

What are the financial projections for REYVOW?

GlobalData forecasts REYVOW to generate $584 million in global sales by 2025, capturing a share from triptan prescriptions for unresponsive patients and those with cardiovascular problems.

Sources

1. Pharmaceutical Technology: "Eli Lilly set to lead the migraine market with new first-in-class drug approval"[1]
2. Daiichi Sankyo: "FY2022 Financial Results Presentation"[2]
3. PR Newswire: "Lilly's REYVOW™ (lasmiditan), The First and Only Medicine in a New Class of Acute Treatment for Migraine, Receives FDA Approval"[3]
4. FiercePharma: "Lilly's migraine reliever Reyvow cleared for launch, setting up 2020 debut"[4]
5. Eli Lilly Investor Relations: "Lilly Reports Strong Fourth-Quarter and Full-Year 2019 Financial Results"[5]

Last updated: 2024-12-16